Slide 1: Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases
mesoblast For personal use only Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Operational Highlights & Financial Results for the Year Ended June 30, 2022 August 2022 ASX: MSB; Nasdaq: MESO
Slide 2: Cautionary Note Regarding Forward-Looking Statements
For personal use only CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, le
Slide 3: Our Mission
For personal use only Our Mission Mesoblast is committed to bringing to market innovative cellular medicines to treat serious and life-threatening illnesses
Slide 4: Late-Stage Clinical Pipeline
Late-Stage Clinical Pipeline For personal use only 1. JCR Pharmaceuticals Co., Ltd. (JCR), has the right to develop mesenchymal stromal cells (MSCs) in certain fields for the Japanese market, including for the treatment of hematological malignancies, such as Graft vs Host Disease, and for hypoxic is
Slide 5: Near Term Milestones
Near Term Milestones For personal use only Remestemcel-L ❑ BLA resubmission for remestemcel-L in children with SR-aGVHD expected to be filed this quarter, with potential US approval Q1 CY2023 ❑ Mesoblast and Vanderbilt University Medical Center, which coordinates a clinical trial network at over 40
Slide 6: Financial Results for the Period Ended June 30, 2022
For personal use only Financial Results for the Period Ended June 30, 2022 Rexlemestrocel-L Chronic Low Back Pain (CLBP) due to Degenerative Disc Disease (DDD) Commercialization – Market Overview 6 Manufacturing Remestemcel-L mesoblast © Lonza, reproduced with permission
Slide 7: Financial Highlights
Financial Highlights For personal use only ❑ Total Revenue from royalties and milestones increased 37% to US$10.2 million for FY2022 compared to US$7.5 million for FY2021 ❑ Royalties from sales of TEMCELL® HS Inj.1 sold in Japan by our licensee in FY2022, were US$8.7 million and US$9.8 million on a
Slide 8: Quarterly Net Operating Cash Burn has been significantly reduced
Quarterly Net Operating Cash Burn has been significantly reduced For personal use only FY21 US$100.7m US$m 35% reduction of US$35 million FY22 US$65.8m ❑ Quarterly net operating cash burn has been reduced over the last 6 quarters. 8 mesoblast
Slide 9: Reduction in R&D Spend; Steady Investment in Manufacturing
Reduction in R&D Spend; Steady Investment in Manufacturing For personal use only Jun 30, Jun 30, P&L for the 12 months ended 2022 2021 ❑ Decreased R&D Spend: (US$m) 38% reduction ($20.2m) predominantly due to reduced spend on Total Revenue 10.2 7.5 clinical trial activities. Research and development
Slide 10: Clinical Pipeline: Current Status and Anticipated Milestones
For personal use only Clinical Pipeline Current Status and Anticipated Milestones 10 mesoblast
Slide 11: Remestemcel-L: Steroid-Refractory Acute Graft Versus Host Disease
Remestemcel-L: Steroid-Refractory Acute Graft Versus Host Disease Significant Unmet Need with High Mortality For personal use only Treatment Options Burden of Illness Market Opportunity Corticosteroids are first-line Acute GVHD is a life- More than 30,000 allogeneic therapy for aGVHD threatening com
Slide 12: Remestemcel-L for Steroid-Refractory GVHD: Outcomes in 309 Children
Remestemcel-L for Steroid-Refractory Graft Versus Host Disease Consistent Efficacy and Safety Outcomes in a Total of 309 Children from Three Studies For personal use only Remestemcel-L was used as first-line therapy in a randomized controlled Phase 3 trial of 260 patients, with SR-aGVHD, including 2
Slide 13: Greater Day 28 Response and Day 180 Survival with Baseline MAP ≥ 0.29
Remestemcel-L for Steroid-Refractory Graft Versus Host Disease Significantly Greater Day 28 Overall Responses and Day 180 Survival in Steroid-Refractory Patients with Baseline MAP ≥ 0.29 For personal use only Response by Baseline MAP Survival by Baseline MAP Response by baseline MAP Survival by Base
Slide 14: Plan for BLA Resubmission for Steroid-Refractory GVHD
Remestemcel-L: Plan for BLA Resubmission for Steroid-Refractory Graft Versus Host Disease In response to FDA guidance, Mesoblast has optimized a potency assay that was in place at the time of the 54-patient Phase 3 trial in children with SR-aGVHD For personal use only Mesoblast believes that the pro
Slide 15: Remestemcel-L for ARDS due to COVID-19
Remestemcel-L for Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 Remestemcel-L Plus Dexamethasone Shows Synergy in Mortality Reduction and Improvement in ARDS Severity* in Exploratory Population < 65 years old For personal use only Treated Patients (mITT) < 65 years old on Treated Patien
Slide 16: Regulatory Pathway to Potential EUA for COVID-19 ARDS
Remestemcel-L: Regulatory Pathway to Potential EUA for COVID-19 ARDS For personal use only Acute respiratory distress syndrome (ARDS) remains a major cause of mortality for COVID-19 patients who are immunocompromised, unvaccinated, or with comorbidities, as well as those with seasonal influenza and
Slide 17: Rexlemestrocel-L – Opportunity in Chronic Low Back Pain
Rexlemestrocel-L – Opportunity in Chronic Low Back Pain A New Paradigm for Treatment of Chronic Low Back Pain due to Degenerative Disc Disease For personal use only Burden of Illness Treatment Options Market Opportunity • Back pain causes more • Minimal treatment options • Over 7m patients are disab
Slide 18: The Patient Treatment Journey
The Patient Treatment Journey Rexlemestrocel-L Potential for First-Line CLBP associated with DDD, Refractory to Conservative Treatment For personal use only Rexlemestrocel-L targeting moderate-to-severe DCLBP Conservative Interventional Opioid Surgery Treatments Therapies Analgesics ❑ NSAIDs ❑ Epidu
Slide 19: Phase Trial Outcomes – Rexlemestrocel-L for Chronic Low Back Pain
Phase 3 Trial Outcomes – Rexlemestrocel-L for Chronic Low Back Pain Single Injection of Rexlemestrocel-L + HA Results in >Three Years of Pain Reduction For personal use only Greatest pain reduction was observed in the pre-specified population of subjects with CLBP duration shorter than the baseline
Slide 20: Market Access & Pricing Insights
Market Access & Pricing Insights: Pricing will be Driven by Overall Value Offering; US Reference Pricing Suggests Higher Price Points for Disease Modifying Agents For personal use only ~$1.2k - $2.5k ~$9k - $15k+ ~$32.2k ~$45.2k ~$77.5k Annual Cost of Branded Pain Annual Cost of Branded Disease Modi
Slide 21: Preparing for Next Phase Trial in Chronic Low Back Pain
Rexlemestrocel-L – Preparing for Next Phase 3 Trial in Chronic Low Back Pain For personal use only FDA Office of Tissues and Advanced Therapies (OTAT) agreed with Mesoblast’s proposal for mean pain reduction at 12 months to serve as the primary endpoint of the next trial, with mean functional improv
Slide 22: Rexlemestrocel-L – Chronic Heart Failure
Rexlemestrocel-L – Chronic Heart Failure Rising Incidence & High Mortality For personal use only ❑ Cardiovascular disease (CVD) remains the leading cause of death in the United States 1 ❑ Heart failure affects 6.5 million patients in the US and 26 million patients globally. As populations age, the p
Slide 23: The Patient Treatment Journey: Chronic Heart Failure
The Patient Treatment Journey Rexlemestrocel-L for Chronic Heart Failure For personal use only Treatment Algorithm in Progressive Heart Failure Progressive Vascular (Endothelial) Dysfunction and Heart Failure Early Mesoblast Target Market ▪ ACEI or ARB ▪ Statins Chronic Heart Failure1 ▪ Beta blocker
Slide 24: Rexlemestrocel-L: Phase Trial in HFrEF
Rexlemestrocel-L: Phase 3 Trial in Heart Failure with Reduced Ejection Fraction (HFrEF) Rexlemestrocel-L Improved Left Ventricular Systolic Function, as Measured by Left Ventricular Ejection Fraction (LVEF) at 12 Months: Potential Early Surrogate Endpoint For personal use only ➢ In all treated patie
Slide 25: DREAM-HF Phase Trial in HFrEF
DREAM-HF Phase 3 Trial in HFrEF Rexlemestrocel-L Reduced Incidence of 3-Point Composite MACE - CV Death, MI or Stroke - Compared to Controls Across All 537 Treated Patients, with Enhanced Effect in Those with Active Inflammation as Measured by CRP >2 For personal use only Time-to-First-Event (TTFE)
Slide 26: Major Clinical & Regulatory Milestones Next Months
Major Clinical & Regulatory Milestones Next 12 Months Remestemcel-L For personal use only FDA filing BLA this quarter for remestemcel-L in the treatment of SR-aGVHD Potential FDA approval of BLA six months after filing, and planned US product launch in Q1 CY2023 Mesoblast and Vanderbilt University M
Slide 27: Thank You
For personal use only Thank You mesoblast